StrokeNCT03848364
Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
A study testing Hip Hop Stroke 2.0 in people with Stroke, run by Columbia University at 1 site in United States.
Trial summary
This study aims to disseminate Hip Hop Stroke 2.0 (HHS2.0) to a more heterogeneous (urban, suburban, and rural population) via NYS Stroke Centers through a partnership with the New York State Department of Health (NYSDOH) Stroke Designation Program. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Hip Hop Stroke 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,706 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2015to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools located in the 47 hospital (stroke center) geographic catchment areas
- Schools with 4th and/or 5th grade classes and have ascertained the following: student bodies have at least 50 students in each of these grades, diverse socio-demographic NYS communities, and computer resources / internet access required for the implementation of the HHS program.
Who cannot join
- Special education school with a student body comprised of those with learning disabilities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
This study aims to disseminate Hip Hop Stroke 2.0 (HHS2.0) to a more heterogeneous (urban, suburban, and rural population) via NYS Stroke Centers through a partnership with the New York State Department of Health (NYSDOH) Stroke Designation Program. This digital program is a second part to an original Hip Hop Stroke program where study showed effectiveness at communicating stroke awareness. In this study, the investigator proposes to intervene in school classrooms with the Hip Hop Stroke 2.0 (HHS2.0) digital program, geared towards children aged 9 to 11 years.
Primary Aims:
Read more
Aim 1: To identify contextual factors, such as barriers and facilitators, that influence uptake of the HHS program in a new, heterogeneous sample at the Stroke Center and local school levels.
Hypothesis 1: Contextual factors at the Stroke Center and local school levels will lead to differential uptake of HHS.
Aim 2: To determine whether Stroke Center implementation of the HHS program leads to increased stroke literacy of local students by cross-validating outcomes with the results of our Randomized Clinical Trial.
Hypothesis 2: Stroke Center implementation will lead to increased stroke literacy of local students.
Secondary Aims:
Aim 3: To assess the determinants of high performance implementation and effectiveness under real world practice conditions.
Aim 4: To evaluate the costs associated with HHS program implementation.
Read the detailed description
Despite effective Acute Stroke Treatment, fewer than 10% of patients in the United States receive them. The largest barrier to this treatment are pre-hospital delays which include limited to no, knowledge of stroke signs and symptoms and the intent seek care. While there is abundance of stroke education materials available, studies continue to reveal severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention measures).
A mere 7% of ischemic stroke events in the US receive thrombolysis (t-PA) therapy1 due to delayed hospital arrival, most often related to the failure to recognize stroke symptoms and to call 911 immediately. Efforts to improve the public's stroke literacy have been driven by mass media stroke education campaigns that include public service announcements and print advertising. However, these efforts have failed to have an effect on 911 use (the major determinant of early hospital arrival) beyond the funding period for the specific media campaign. Stroke Centers may represent more sustainable channels for public stroke education initiatives promoting the use of ambulance services.
State Departments of Health and the Joint Commission regulate Stroke Center hospitals through an accreditation process that requires the fulfillment of certain stroke care measures. Notably, one of these regulatory requirements is community stroke education by the hospital; however, these are underdeveloped, and lack guidelines and evaluation metrics. Consequently, stroke education efforts by Stroke Centers are often poorly delivered and do not use evidence-based approaches.
The program helps schools fulfill NYS health education requirements through its primordial prevention modules. Children are also taught to teach stroke information to their parents/caregivers. HHS2.0 has shown to be effective in the real world setting through several studies, including an Randomized Clinical Trial (RCT) involving more than 3,000 predominantly Black and Hispanic urban school children aged 9-11 years. These studies found that children can and will: (1) learn how to recognize stroke, including self-efficacy for calling 911 when they witness stroke, and retain this knowledge for at least 15 months, (2) communicate stroke literacy successfully to their parents and grandparents who retain this knowledge for at least 3 months, and (3) actually call 911 when they witness stroke symptoms occurring in their homes or community.
This project is an outgrowth of our previously funded RCT (R01NS067443), in which we developed and established the effectiveness of a novel intervention to teach economically challenged minority residents of New York City to recognize stroke symptoms and know the correct response - call 911 (stroke literacy).
- Conditions
- Stroke
- Being tested
- Hip Hop Stroke 2.0
- Keywords
- Stroke, Education, Hip Hop Stroke, Community, Nutrition, Schools, Stroke Centers
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Hop Stroke 2.0Behavioural
Also called HHS2.0
HHS2.0 is an innovative, multimedia program, a brief 3-hour (1hr/day for 3 days), school-based intervention designed to educate at-risk populations concerning stroke symptoms and calling 911 immediately in the event they occur (stroke literacy). HHS2.0 is accessed and delivered via a web link online as self-administered, interactive modules that target 4th and 5th grade children in the school system (ages 9-11) using narrative cartoons and multimedia games.
| Study group | Role | What they receive |
|---|---|---|
| Hip Hop Stroke 2.0 intervention group | Experimental | Students in 4th and 5th grade will receive the intervention, Hip Hop Stroke 2.0, disseminated and implemented by local Stroke Centers - uses a framework of Child-Mediated Health Communication to make children "stroke literate" and then empower these stroke literate students with the tools required to successfully communicate actionable stroke knowledge (recognition of stroke symptoms and the urgency of calling 911) to their parents and grandparents at home. Receives: Behavioral: Hip Hop Stroke 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stroke Literacy Score
The Investigator will assess stroke literacy among 4th and 5th grade students with the validated Stroke Literacy Action Measure using a pre-post- test design. Literacy will be determined by percentage of questions answered correctly. The greater percentage correct indicates a better outcome.
Measured: Baseline, at least 3 days from baseline
Secondary outcomes (4)
Average number of barriers influencing program uptake
The Investigator will find the average rate of factors influencing program update through the use of the Consolidated Framework for Implementation (CFIR). The CFIR will be measured by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate these averages.
Measured: Baseline, at least 1 year from baseline
Average number of facilitators influencing program uptake
The Investigator will find the average rate of factors influencing program update through the use of the Consolidated Framework for Implementation (CFIR). The CFIR will be measured by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate these averages.
Measured: Baseline, at least 1 year from baseline
Average number of determinants yielding high performance implementation and effectiveness
Using data from Aim 1 and Aim 2, the Investigator will analyze contextual data from each Stroke Center in relation to the data generated from RE-AIM variables. The Investigator will assess the average number of factors/elements influencing the adoption, implementation, and maintenance of the intervention at the Stroke Center and the local school level
Measured: Baseline, up to 2 years
Average total cost associated with program implementation
The Investigator will conduct cost analyses from two complementary perspectives: 1) implementing agencies (primary cost analysis) and 2) society as a whole (secondary cost analysis). The Investigator will first estimate costs, and variations therein, based on the experience of participating Stroke Centers and schools (implementing agencies). The Investigator will develop estimates of the total cost of the HHS program, its key components and activities, and costs per participant using the resource cost method and look at the average totals.
Measured: Baseline, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start17 Dec 2015
- Primary completion28 Feb 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stroke Centers who agree to participate will designate a Stroke coordinator who will recruit at least 2 schools from their area with 4th and/or 5th grades. Coordinators will receive a customizable electronic training package to introduce content, and recruit strategies to engage schools. They will in turn coordinate with School Champions (school designated member), who will receive program training, to implement the program. School Champion will be responsible for the distribution of Opt-Out consent forms, scheduling programming (including computer use), and coordinating with the Stroke Champion and research staff. Regarding maintenance, Stroke Coordinators and School Champions will complete and exit survey, and to promote annual implementation in recruited schools.
- Masking
- None (open label)
- Enrolment
- 1,706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olajide Williams, Columbia University
- Investigators
- Olajide Williams, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848364
- Sponsor's protocol ID
- AAAQ6052
- Other IDs
- 2R01NS067443-06
- Status last verified
- May 2024
- First submitted
- 19 Feb 2019
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Hop Stroke: Statewide Dissemination of a School-based Public Stroke Education Intervention
- ClinicalTrials.gov ID
- NCT03848364
- Acronym / sponsor ID
- AAAQ6052
- Conditions
- Stroke
- Keywords
- Stroke, Education, Hip Hop Stroke, Community, Nutrition, Schools, Stroke Centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,706 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to disseminate Hip Hop Stroke 2.0 (HHS2.0) to a more heterogeneous (urban, suburban, and rural population) via NYS Stroke Centers through a partnership with the New York State Department of Health (NYSDOH) Stroke Designation Program. This digital program is a second part to an original Hip Hop Stroke program where study showed effectiveness at communicating stroke awareness. In this study, the investigator proposes to intervene in school classrooms with the Hip Hop Stroke 2.0 (HHS2.0) digital program, geared towards children aged 9 to 11 years.
Primary Aims:
Aim 1: To identify contextual factors, such as barriers and facilitators, that influence uptake of the HHS program in a new, heterogeneous sample at the Stroke Center and local school levels.
Hypothesis 1: Contextual factors at the Stroke Center and local school levels will lead to differential uptake of HHS.
Aim 2: To determine whether Stroke Center implementation of the HHS program leads to increased stroke literacy of local students by cross-validating outcomes with the results of our Randomized Clinical Trial.
Hypothesis 2: Stroke Center implementation will lead to increased stroke literacy of local students.
Secondary Aims:
Aim 3: To assess the determinants of high performance implementation and effectiveness under real world practice conditions.
Aim 4: To evaluate the costs associated with HHS program implementation.
Detailed description
Despite effective Acute Stroke Treatment, fewer than 10% of patients in the United States receive them. The largest barrier to this treatment are pre-hospital delays which include limited to no, knowledge of stroke signs and symptoms and the intent seek care. While there is abundance of stroke education materials available, studies continue to reveal severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention measures).
A mere 7% of ischemic stroke events in the US receive thrombolysis (t-PA) therapy1 due to delayed hospital arrival, most often related to the failure to recognize stroke symptoms and to call 911 immediately. Efforts to improve the public's stroke literacy have been driven by mass media stroke education campaigns that include public service announcements and print advertising. However, these efforts have failed to have an effect on 911 use (the major determinant of early hospital arrival) beyond the funding period for the specific media campaign. Stroke Centers may represent more sustainable channels for public stroke education initiatives promoting the use of ambulance services.
State Departments of Health and the Joint Commission regulate Stroke Center hospitals through an accreditation process that requires the fulfillment of certain stroke care measures. Notably, one of these regulatory requirements is community stroke education by the hospital; however, these are underdeveloped, and lack guidelines and evaluation metrics. Consequently, stroke education efforts by Stroke Centers are often poorly delivered and do not use evidence-based approaches.
The program helps schools fulfill NYS health education requirements through its primordial prevention modules. Children are also taught to teach stroke information to their parents/caregivers. HHS2.0 has shown to be effective in the real world setting through several studies, including an Randomized Clinical Trial (RCT) involving more than 3,000 predominantly Black and Hispanic urban school children aged 9-11 years. These studies found that children can and will: (1) learn how to recognize stroke, including self-efficacy for calling 911 when they witness stroke, and retain this knowledge for at least 15 months, (2) communicate stroke literacy successfully to their parents and grandparents who retain this knowledge for at least 3 months, and (3) actually call 911 when they witness stroke symptoms occurring in their homes or community.
This project is an outgrowth of our previously funded RCT (R01NS067443), in which we developed and established the effectiveness of a novel intervention to teach economically challenged minority residents of New York City to recognize stroke symptoms and know the correct response - call 911 (stroke literacy).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stroke Centers who agree to participate will designate a Stroke coordinator who will recruit at least 2 schools from their area with 4th and/or 5th grades. Coordinators will receive a customizable electronic training package to introduce content, and recruit strategies to engage schools. They will in turn coordinate with School Champions (school designated member), who will receive program training, to implement the program. School Champion will be responsible for the distribution of Opt-Out consent forms, scheduling programming (including computer use), and coordinating with the Stroke Champion and research staff. Regarding maintenance, Stroke Coordinators and School Champions will complete and exit survey, and to promote annual implementation in recruited schools.
| Arm | Type | Receives |
|---|---|---|
| Hip Hop Stroke 2.0 intervention group | Experimental | Behavioral: Hip Hop Stroke 2.0Students in 4th and 5th grade will receive the intervention, Hip Hop Stroke 2.0, disseminated and implemented by local Stroke Centers - uses a framework of Child-Mediated Health Communication to make children "stroke literate" and then empower these stroke literate students with the tools required to successfully communicate actionable stroke knowledge (recognition of stroke symptoms and the urgency of calling 911) to their parents and grandparents at home. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Schools located in the 47 hospital (stroke center) geographic catchment areas
- Schools with 4th and/or 5th grade classes and have ascertained the following: student bodies have at least 50 students in each of these grades, diverse socio-demographic NYS communities, and computer resources / internet access required for the implementation of the HHS program.
Key exclusion criteria (1 listed)
- Special education school with a student body comprised of those with learning disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip Hop Stroke 2.0Also: HHS2.0HHS2.0 is an innovative, multimedia program, a brief 3-hour (1hr/day for 3 days), school-based intervention designed to educate at-risk populations concerning stroke symptoms and calling 911 immediately in the event they occur (stroke literacy). HHS2.0 is accessed and delivered via a web link online as self-administered, interactive modules that target 4th and 5th grade children in the school system (ages 9-11) using narrative cartoons and multimedia games. | Behavioural | Hip Hop Stroke 2.0 intervention group |
Primary outcome
Change in Stroke Literacy Score
Time frame: Baseline, at least 3 days from baseline
The Investigator will assess stroke literacy among 4th and 5th grade students with the validated Stroke Literacy Action Measure using a pre-post- test design. Literacy will be determined by percentage of questions answered correctly. The greater percentage correct indicates a better outcome.
4 secondary outcomes
Average number of barriers influencing program uptake
Time frame: Baseline, at least 1 year from baseline
Average number of facilitators influencing program uptake
Time frame: Baseline, at least 1 year from baseline
Average number of determinants yielding high performance implementation and effectiveness
Time frame: Baseline, up to 2 years
Average total cost associated with program implementation
Time frame: Baseline, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olajide Williams, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Hop Stroke 2.0 in people with Stroke, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stroke Literacy Score (time frame: Baseline, at least 3 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.